Open AccessReal-World Data for the Drug Development in the Digital Era
Author(s) -
Xianchen Liu
Publication year - 2022
Publication title -
journal of artificial intelligence and technology
Language(s) - English
Resource type - Journals
ISSN - 2766-8649
DOI - 10.37965/jait.2022.0091
Subject(s) - real world data , real world evidence , drug development , clinical trial , randomized controlled trial , medicine , gold standard (test) , clinical practice , drug , medical physics , intensive care medicine , data science , computer science , pharmacology , surgery , family medicine
Randomized clinical trials (RCTs) have long been recognized the gold standard for regulatory approval in the drug development. However, RCTs may not be feasible in some diseases and/or under certain situations and findings from RCTs may not be generalized to real-world patients in the routine clinical practice. Real-world evidence (RWE) generated from various real-world data has become more and more important for the drug development and clinical decision making in the digital era. This paper described real-world data, RWE, and RWE generation, followed by the characteristics and differences between RCTs and RWE studies. Furthermore, the challenges and limitations of real-world data and RWE studies were discussed.